a study of tiragolumab in combination with atezolizumab in chemotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic pd-l1-selected non-small cell lung cancer (nsclc), excluding patients with a sensitizing egfr mutation or alk translocation.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0 or 1 * histologically or cytologically documented locally advanced unresectable nsclc, recurrent, or metastatic nsclc of either squamous or non-squamous histology * no prior systemic treatment for locally advanced unresectable or metastatic nsclc * tumor pd-l1 expression * measurable disease, as defined by recist v1.1 * life expectancy \>=12 weeks * adequate hematologic and end-organ function * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm exclusion criteria: cancer-specific exclusions: * patients with nsclc known to have a sensitizing mutation in the egfr gene or an alk fusion oncogene * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to screening * history of leptomeningeal disease * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * uncontrolled tumor-related pain * uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome general medical exclusions: * pregnant and lactating women * significant cardiovascular disease * severe infections within 4 weeks prior to randomization * major surgical procedure other than for diagnosis within 4 weeks prior to randomization treatment-specific exclusions: * history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in chinese hamster ovary cells or any component of the atezolizumab formulation * history of autoimmune disease * prior allogeneic bone marrow transplantation or solid organ transplantation * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest ct scan * positive test for human immunodeficiency virus (hiv) and/or active hepatitis b or hepatitis c or active tuberculosis * administration of a live, attenuated vaccine within 4 weeks prior to randomization